The U.S. Food and Drug Administration said on Monday that it is revising the labeling of all extended-release stimulants to ...

Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items ...

Benlysta is the first and only approved autoinjector biologic for both systemic lupus erythematosus and lupus nephritis ...

The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to ...

Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. Food and Drug Administration ...

San Francisco-based Wildtype, a startup that is pioneering cell-grown salmon, cleared a U.S. Food and Drug Administration ...

Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

The Food and Drug Administration has approved Harliku (nitisinone) for the reduction of urine homogentisic acid in adult patients with alkaptonuria.

The FDA published a report highlighting a "severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy" as a potential signal of serious risk with Vyvgart Hytrulo (efgartigimod alfa ...

The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.